1. Field of the Invention
The present invention relates generally to a device for treating postpartum mothers. More particularly, the present invention relates to a low-cost device for treating postpartum hemorrhaging.
2. Description of the Related Art
Postpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide. There are over 14 million cases of PPH every year, and approximately 150 thousand of those cases end in death. The majority of these deaths occur in resource-constrained settings, with an estimated half occurring in sub-Saharan Africa and a third in South Asia. Additionally, there are over 20 million women living with chronic illnesses, such as anemia, which result from PPH. Moreover, a child is ten times more likely to die before a second birthday if the mother dies from PPH.
PPH is defined as the loss of ≧500 ml of blood within twenty four hours after the birth of a child. PPH arises due to complications during the third and fourth stages of labor. The main cause of PPH is uterine atony, which accounts for up to 80% of the cases. Additional causes include retained placenta, genital tract trauma, and bleeding disorders.
PPH is largely manageable with access to adequate resources. However, in developing nations with their often, resource-constrained, medical facilities, PPH is much more devastating. The nearest referral hospital in such nations can often be many hours away from a birthing mother—this can result in a potentially dangerous situation when one considers that it can take less than two hours for a woman to bleed to death from a PPH. Additionally, the screening of at-risk women for earlier referrals to nearby hospitals is challenging because two-thirds of pregnant women display no risk factors for PPH.
There are a number of commercially available medical devices available for treating a woman who is suffering from a PPH. Most of these function by trying to stop or prevent bleeding by applying pressure on a women's uterine wall which is the likely location or source of bleeding. This pressure applying step is typically accomplished by inserting an un-inflated balloon tamponade into the uterus and then inflating it with a saline solution. The volume of the saline fill is pre-determined using ultrasound, or is achieved incrementally with observations for bleeding in between each aliquot to determine if a sufficient volume has been added in an attempt to apply pressure to the source of the PPH and thereby stop it.
Examples of these commercially available devices include the “Bakri SOS Postpartum Balloon (Bakri)” (available from Cook Medical), the “Sengstaken-Blakemore Oesophageal Balloon (S-B),” the “Balloon Tamponade Catheter (BT-Cath)” (available from Utah Medical), the “Rusch Hydrostatic Catheter Balloon (HCB),” and the “Belfort-Dildy Obstetric Tamponade (B-D)” (available from Glenveigh Medical).
All of these devices share the distinction of being comparatively costly and therefore prohibitively expensive for use in developing countries where medical device cost considerations can often be paramount. Except for the HCB device, they all also share the characteristics of being comparatively complicated to use and non-reusable; plus they have maximum fill capacities of only about 500 ml which is substantially less than the typical volume of the entire uterine cavity (i.e., up to 1800 ml).
Uncertainty around the proper fill volume and the variability from woman to woman is reported to be the cause of the major reason why these devices fail—i.e., insufficient inflation volumes allow them, when in service, to slip downward and fall out of a patient's uterus. To prevent this occurrence, additional saline volumes are added to the balloon and/or gauze packing is often used to hold these devices in place. However, significant health risks can arise from this practice, including the concealment of ongoing bleeding.
Furthermore, the Bakri device has the disadvantage of being time-consuming to fill, as its recommended use entails utilizing ultrasound to estimate the volume of the uterus prior to filling the device. Meanwhile the S-B and HCB devices were not designed to be used in addressing PPH situations and they require some on-site modifications prior to their use for such purposes. Many health practitioners are reportedly not comfortable with such other-than-intended-use applications; this has apparently limited these devices' use in PPH situations.
There is an innovated-out-of-necessity, cost-effective alternative to these commercial devices. It is an “Improvised Condom Tamponade (ICT)” device that uses a condom tied to an inexpensive catheter to create a device for managing PPH.
Additionally, there are reportedly research development programs that are directed towards developing an alternative, low-cost, balloon tamponade device for use in managing PPH cases in developing countries. These include the single-use, balloon-included “Uterine Balloon Tamponade (UBT)” (which is under development by the non-profit PATH) and the condom-using “Tampostat” (which is under development by Jibon Health Technologies).
Further disclosures regarding the state of the technology in the field of the present invention are also found in various patent documents. See, e.g., U.S. Pat. Nos. 8,123,773 and 6,676,680, and USPAP 2004/0030352.
Thus, despite the existence of significant technology and commercially available devices for addressing PPH situations, we see that, because of the various problems with many of these devices, there is still a need for the development of improved devices which can help address PPH and other uterine wall bleeding situations.